The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Lts with the FDA for Single-use Video Bronchoscopes, Digital Controller.
| Device ID | K213782 |
| 510k Number | K213782 |
| Device Name: | Single-Use Video Bronchoscopes, Digital Controller |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Micro-Tech (Nanjing) Co., Lts No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Lts No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone Nanjing, CN 210032 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-03 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503571132 | K213782 | 000 |
| 16932503571125 | K213782 | 000 |
| 16932503571118 | K213782 | 000 |